FDA Issues Warning Letters to India and China API Manufacturers

The US Food and Drug Administration has recently issued Warning Letters to two India-based and one China-based active pharmaceutical ingredient (API) manufacturers for cGMP violations at their respective manufacturing facilities. These include drug manufacturing facilities in India run by Megafine Pharma and Badrivishal Chemicals & Pharmaceuticals, based in Mumbai and Talegaon Dabhade, India, respectively, and a drug manufacturing facility in China run by Lumis Global Pharmaceuticals, headquartered in Wuhan, China.

The FDA’s observations during a September 19-23, 2016 inspection of Megafine’s Gujara, India drug manufacturing facility included a failure to use scientifically sound test procedures to demonstrate drug purity and a quality control oversight wherein adulterated material from an FDA-designated import alert facility was approved for the manufacture of an API intermediate at the facility.

The FDA’s August 16-19, 2016 inspection of Badrivishal’s Taluka Maval, India drug manufacturing facility yielded observations that included an inadequately monitored and controlled water purification system that poses a risk to the safety of the drugs produced in the facility; improperly handled records by way of a large number of trash bags containing torn original laboratory and production records that did not match official records; and unverified analytical testing methods by a contract testing laboratory as well as unexplained test discrepancies that were not investigated.

During its inspection of Lumis’ Wuhan, China drug manufacturing facility in September 26-28, 2016, the FDA noted that the company failed to transfer the identity of original API manufacturers on Lumis’ certificates of analysis (COA) issued to customers by omitting the original manufacturers name and address on the COAs and poorly documented relabeling operations. In addition, the FDA found that Lumis improperly held unlabeled material in an area meant for holding APIs to be shipped to customers, risking mix-up in material as well as loss of API identity. The FDA also observed the misbranding of the gabapentin API, which were relabeled with Lumis’ name as the manufacturer, when in fact Lumis is not the original manufacturer of this API, according to the agency.